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Summary of safety and clinical performance template

Summary of safety and clinical performance template

Clarify your device’s safety and clinical value with a template designed to meet MDR requirements and speed up your reporting process.

Use this template
or download pdf
Summary of safety and clinical performance template

Clarify your device’s safety and clinical value with a template designed to meet MDR requirements and speed up your reporting process.

Use this template
or download pdf

About the Summary of safety and clinical performance template

Bringing a medical device to market comes with a heavy load of documentation, including the summary of safety and clinical performance (SSCP). If you’re a regulatory affairs manager or medical writer, a summary of safety and clinical performance template helps you standardize your reports and speed up the process across your team. This template gives you a systematic framework for collecting and presenting data in line with regulatory expectations.

When to use the summary of safety and clinical performance template

A summary of safety and clinical performance is a regulatory must-have, especially under EU MDR. If you’re preparing documentation for Class IIa, IIb, or III devices, using a template gives ypu a faster way to stay organized and consistent across submissions.

Use this template to clearly communicate clinical benefits and known risks to notified bodies or end users. It’s especially helpful during conformity assessments, updates for legacy devices, or when launching new models under the same family.

You can also use it to align internal teams, such as regulatory, clinical, and QA, by giving everyone the same format to work with. This approach saves you time and prevents compliance errors while supporting faster approvals down the line.

Key elements of the summary of safety and clinical performance template

This template gives you a roadmap to structure complex data in a way that’s compliant and easy to follow. Here are its core elements:

  • Device overview – Start with the essentials: the device name, model number, manufacturer, and its intended use. This section provides quick context to readers unfamiliar with your product.
  • Safety information – Highlight known risks, contraindications, and precautions. This part helps users and reviewers quickly assess the risk profile of your device and how those risks are being managed.
  • Clinical performance data – Summarize how well your device performs based on real clinical data. Include outcomes, target populations, and supported indications to show both effectiveness and relevance.
  • Labelling and usage instructions – Outline the instructions for use, any symbols used, and the validated shelf life. Clear labeling supports safe operation and regulatory approval.

Streamline your reporting process now

Download this template to create reports with more clarity and confidence. It gives you a solid foundation to present your data precisely, from risk summaries to clinical outcomes, so you can focus on quality. With customizable fields, intuitive layout, and clear prompts, you’ll work faster and avoid missing critical details. It’s built to support your team’s workflow, whether you’re handling one device or twenty.

Related categories

  • Health and safety management templates
  • Quality management templates
  • Health care templates
  • Quality assurance templates
  • Safety templates
Preview of the template
entity_item!!!
Page 1
Device Overview
Device Name
Model Number
Manufacturer
Intended Use
Safety Information
Summary of Safety Data
Contraindications
Warnings and Precautions
Clinical Performance
Summary of Clinical Data
Intended Patient Population
Supported Clinical Indications
Labeling
Instructions for Use
Symbols Used
Shelf Life

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Related resources

Access a complete set of resources aimed at maximizing safety, quality, and operational excellence, including detailed guides, related templates, and real-world use cases.

Topic guides

Read in-depth guides covering key topics related to this article.

ISO 13485: A guide to quality management in medical devicesNavigating medical device regulations: Key steps for compliance Mastering good clinical practice: A step-by-step guide
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Template collections

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Frequently asked questions

What’s the difference between an SSCP and a clinical evaluation report?

The summary of safety and clinical performance (SSCP) is a public-facing document intended for both professionals and laypersons, while the clinical evaluation report (CER) is a detailed internal regulatory document submitted to the notified body. You can think of the SSCP as the simplified, digestible version that communicates key points clearly without giving away confidential data.

Who is responsible for writing the summary of safety and clinical performance?

In most companies, the regulatory affairs or clinical affairs team takes the lead, often collaborating with QA and medical writing teams. If you’re in a smaller company, this might fall on a single regulatory lead. It’s important that whoever writes it understands both the device’s clinical background and regulatory nuances, since errors here can delay your approval.

How detailed should the clinical data section be?

You don’t need to include full study reports, but you do need to summarize the main findings clearly: what was studied, how, with whom, and what the outcomes were. Use plain language where possible, especially if your device is Class III, since your SSCP will be publicly available. What’s key here is clarity and relevance.


This template, developed by Lumiform employees, serves as a starting point for businesses using the Lumiform platform and is intended as a hypothetical example only. It does not replace professional advice. Companies should consult qualified professionals to assess the suitability and legality of using this template in their specific workplace or jurisdiction. Lumiform is not liable for any errors or omissions in this template or for any actions taken based on its content.
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